MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RADIAL JAW 4; FORCEPS, BIOPSY, NON-ELECTRIC

Model Number	M00513441
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental a will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 pediatric biopsy forceps was used in a biopsy procedure performed on (b)(6) 2018.According to the complainant, during the procedure, on the endoscope image, a string/thread like tiny object, similar to lint, was observed on the cup when opening the forceps.Another radial jaw 4 pediatric biopsy forceps was used to complete the procedure.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 pediatric biopsy forceps was used in a biopsy procedure performed on (b)(6) 2018.According to the complainant, during the procedure, on the endoscope image, a string/thread like tiny object, similar to lint, was observed on the cup when opening the forceps.Another radial jaw 4 pediatric biopsy forceps was used to complete the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
H6: problem code 2944 captures the reportable event of foreign material present in device.H10: investigation results: visual inspection found the returned device does not have any visible failure.No foreign matter was noted on the device.The most probable cause classification is "no problem detected" since the device complaint or problem cannot be confirmed.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly, and performance specifications at the time of release for distribution.

• Brand Name: RADIAL JAW 4
• Common Device Name: FORCEPS, BIOPSY, NON-ELECTRIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8130676
• Report Number: 3005099803-2018-61667
• Device Sequence Number: 1579759
• Product Code: FCL
• UDI-Device Identifier: 08714729789918
• UDI-Public: 08714729789918
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/15/2021
• Device Model Number: M00513441
• Device Catalogue Number: 1344
• Device Lot Number: 0022125937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• Initial Date Received by Manufacturer: 11/07/2018
• Supplement Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 12/04/2018
• Supplement Report FDA Received Date: 01/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1